Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006125668

FEI Number

3006125668

Entity Name

KIRKSTALL PRECISION LTD

City/State/Country

LEEDS, GB

Establishment Address

Units G4 - G6, Wyther Lane Industrial Estate, LEEDS LS5 3AR, GB

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Kirkstall Precision Ltd (Owner Number: 10042505)

Owner / Operator Contact Address

Units G4 - G6, Wyther Lane Industrial Estate, LEEDS, GB-LDS LS5 3AR, GB

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Osteotec SFI Instrument - awl

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HWJ	Awl	Orthopedic	Class 1	888.4540	2025-08-01
HTO	Reamer	Orthopedic	Class 1	888.4540	2012-12-04
HTQ	Broach	Orthopedic	Class 1	888.4540	2025-08-01
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2013-01-29

Official Correspondent

Clare Firth

US Agent Details

Patrick McCullagh Business: DePuy Synthes Email: pmccull1@ITS.JNJ.com Phone: (267) 3005417

Related Public Records

Same Entity

Kirkstall Precision Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K040336	Synthes (Usa)	SYNTHES (USA) LATERAL ENTRY FEMORAL NAIL SYSTEM	2004-04-12
K083648	Efratgo, Ltd. HI Tech Bio-Surgical	GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL	2009-05-14
K192312	Zimmer GmbH	Zimmer Natural Nail System Cephalomedullary Nails	2019-10-11
K002057	Biomet Orthopedics, Inc.	BROOKER TIBIA NAILS	2000-10-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0021-2015	Biomet, Inc.	1	Compress Face Reamer Product Usage: Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement, tumor resections, revision of previously failed total joint arthroplasty, and trauma.

Similar Registrations

Registration Number	Establishment Name	Location
3005061536	SYMMETRY MEDICAL MANUFACTURING INC	CLAYPOOL, IN, US
3017936978	CARLSMED, INC.	Carlsbad, CA, US
2027467	ALPHATEC SPINE, INC.	Carlsbad, CA, US
9612420	ULRICH GMBH & CO. KG	ULM Baden-Wurttemberg, DE
3036756245	STRAITS ORTHOPAEDICS (MFG) SDN BHD	Perai Pulau Pinang, MY

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006125668. Last updated year: 2026. Please use registration number 3006125668 when referencing this establishment in official correspondence.